Systems and methods for implantable leadless nerve stimulation

• US 7,894,907 B2
• Filed: 06/18/2007
• Issued: 02/22/2011
• Est. Priority Date: 06/20/2006
• Status: Active Grant

• Current Assignee: EBR Systems, Inc.
• Original Assignee: EBR Systems, Inc.
• Inventors: Riley, Richard E., Cowan, Mark W., Brisken, Axel F., Echt, Debra S.
• Primary Examiner(s): Bertram; Eric D.
• Application Number:
  US11/764,592
• Publication Number:
  US 20070293906A1
• Time in Patent Office: 1,345 Days
• Field of Search: 607/46, 607/60, 607/61
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile

Abstract

Systems and methods are disclosed to stimulate nerves to treat medical conditions such as pain, and other conditions, such as, CHF, obesity, incontinence, etc., that could be controlled by the stimulation of the vagal nerves. The invention uses electrical stimulation of the nerve, where vibrational energy from a source is received by an implanted device and converted to electrical energy and the converted electrical energy is used by implanted electrodes to stimulate the pre-determined nerve site. The vibrational energy is generated by a controller-transmitter, which could be implanted or located externally. The vibrational energy is received by a receiver-stimulator, which could be located in the various regions on or around the nerve that needs to be stimulated. The implantable receiver-stimulator stimulates different nerves and regions of a nerve to provide therapeutic benefit.

Claims

1. A method for stimulating a nerve comprising:

implanting in a body of a patient a controller-transmitter at an implantation site to generate acoustic energy, wherein the controller-transmitter comprises acoustic transducers disposed in a housing and one or more physiological sensors disposed on an external surface of the housing, and wherein the one or more physiological sensors are configured to detect one or more physiological parameters;

implanting a receiver-stimulator remotely from the controller-transmitter in nerve tissue of the patient at a nerve tissue stimulation site, wherein the receiver-stimulator comprises one or more stimulation electrodes such that the stimulation electrodes lie in electrical communication with the nerve tissue stimulation site;

sensing one or more physiological parameters directly from the body using the one or more physiological sensors;

generating acoustic energy at the controller-transmitter implantation site using the transducers in the controller-transmitter;

receiving the acoustic energy at the nerve stimulation site using the receiver-stimulator;

converting the received acoustic energy into an electrical nerve stimulation energy output using the receiver-stimulator, wherein the stimulation energy output has at least one of pulse amplitude, pulse duration, duty cycle, and timing based on energy and signal information included in the generated acoustic energy;

delivering the electrical nerve stimulation energy output to the nerve tissue stimulation site using the one or more stimulation electrodes;

sensing the electrical nerve stimulation energy output, wherein the physiological sensors are adapted to sense the electrical nerve stimulation energy output;

adjusting the acoustic energy transmission from the controller-transmitter to compensate for changes in the electrical nerve stimulation energy output of the receiver-stimulator; and

using an external programmer to program one or more settings of the controller-transmitter.

2. A method as in claim 1 wherein the nerve stimulation further comprises:

operating the controller-transmitter such that electrical nerve stimulation energy output is generated by the receiver-stimulator at the predetermined nerve stimulation site;

wherein the predetermined nerve stimulation site is chosen to treat one or more medical conditions chosen from the list comprising headache, facial pain, pelvic pain, heart failure, hypertension, obesity, migraine, neuropsychiatric disorders, urinary, gastrointestinal, urge or stress urinary incontinence, and fecal incontinence.

3. A method of claim 1, wherein receiving comprises receiving the energy output at two or more nerve stimulation sites.

4. A method of claim 3, wherein the signal information stimulates different sites sequentially.

5. A method of claim 3, wherein the signal information stimulates different sites simultaneously.

6. A method as in claim 1, wherein the housing is a hermetically sealed housing.

7. A method as in claim 6, wherein the one or more physiological sensors have a portion within the housing and a portion external to the housing.

8. A method as in claim 7, wherein the one or more physiological sensors are directly connected to a signal processing circuitry of the controller-transmitter.

9. A method as in claim 1, wherein the external programmer transmits a radiofrequency signal and the controller-transmitter comprises circuitry for receiving the radiofrequency signal.

10. A method as in claim 1, wherein the receiver-stimulator consists essentially of an ultrasound transducer which generates a stimulation signal in response to the acoustic energy transmitted by the controller-transmitter, circuitry which rectifies the stimulation signal, and at least one electrode which delivers the rectified signal as the electrical nerve stimulation energy output to nerve tissue.